Tumori Journal Abstract Book - October 2020 - 52

52	
Background: CA19-9 is the reference tumor marker for
mPC, however it is subject to non-specific increase in
presence of cholestasis. We investigated whether cholestasis-normalized values improved the prognostic performance of CA19-9
Methods: Consecutive mPC patients candidate for first-line
chemotherapy were reviewed and baseline CA19-9/BIL,
CA19-9/ALP and CA19-9/GGT ratios were calculated and
compared to raw CA19-9 values for association with overall
survival (OS). Cox-regression analysis with restricted cubic
splines with 5 knots modelling and hazard ratio (HR)
smoothed curves were used to account for non-linearity.
Results: 302 patients with complete data were included.
Raw CA19-9 was predictive of OS only if very high values
(>2000 U/ml) were recorded: median(m) OS for CA19-9
> 2000 vs <2000 3.7 months (mo) vs 9.9 mo, HR 2.91, p
= 0.0004 (results comparable with data from the literature,
e.g. Hess, Lancet Oncol, 2008). Among patients with
CA19-9 <2000 (82%), none of the normalized indexes
was able to improve the prognostic performance of CA199: cox regression p-values of CA19-9/BIL, CA19-9/ALP
and CA19-9/GGT were 0.059, 0.275 and 0.309, respectively. Surprisingly, looking at HR smoothed curves,
CA19-9/ALP ratio was inversely associated with survival.
In fact higher CA19-9/ALP (> 6) was associated with significantly improved survival as compare to CA19-9/ALP
< 6: 20.18 mo vs 8.1 mo (HR 0.39, p = 0,023). This finding is probably due to a direct adverse effect of increasing
values of the denominator (ALP), thus suggesting that
ALP might function in mPC more as proper tumor marker
(it is known that ALP is produced by proliferating tumor
cells) than as non-specific cholestatic marker.
Conclusions: the prognostic value of CA19-9 is not
improved by normalization based on cholestasis indexes.
CA19-9 is prognostically informative only for very high
values (>2000). For patients with CA19-9 < 2000, other
proper tumor markers need to be investigated to refine survival prediction.

C14
Neoadjuvant chemoradiotherapy
and surgery versus surgery alone
in resectable pancreatic cancer:
Long term follow-up results
from a single-center prospective,
randomized, controlled trial
Di Marco M.1, Ricci C.2, Brandi G.1, De Lorenzo S.1, Tovoli F.3,
Carloni R.1, Palloni A.1, Abbati F.1, Grassi E.4, Guido A.5, Morganti
A.G.5, Nigro M.C.5, Rizzo A.5, Ricci A.D.5, Alberici L.6, D'Onofrio M.7,
Minni F.6, Santini D.8, Casadei R.9
1

Department of Experimental, Diagnostic, and Specialty Medicine DIMES, Sant'Orsola-Malpighi Hospital, University of Bologna, Bologna;
2
Department of Internal Medicine and Surgery (DIMEC), Alma Mater

Tumori Journal 106(2S)
Studiorum, S.Orsola-Malpighi Hospital, University of Bologna, Bologna;
Department of Medical and Surgical Sciences, University of Bologna,
Bologna; 4Medical Oncology, Ospedale degli Infermi, Faenza; 5 Department
of Experimental, Diagnostic, and Specialty Medicine - DIMES, Sant'OrsolaMalpighi Hospital, University of Bologna, Bologna; 6 Department of Internal
Medicine and Surgery (DIMEC), Alma Mater Studiorum, S.Orsola-Malpighi
Hospital, University of Bologna, Bologna; 7 Department of Experimental,
Diagnostic, and Specialty Medicine - DIMES, Sant'Orsola-Malpighi Hospital,
University of Bologna, Bologna; 8 Department of Experimental, Diagnostic,
and Specialty Medicine - DIMES, Sant'Orsola-Malpighi Hospital, University
of Bologna, Bologna; 9 Department of Internal Medicine and Surgery
(DIMEC), Alma Mater Studiorum, S.Orsola-Malpighi Hospital, University of
Bologna, Bologna
3

Background: Neoadjuvant chemoradiotherapy has shown
benefits for locally advanced and borderline resectable
pancreatic cancer and several studies seem to show a
potential benefit also for resectable pancreatic cancer.
Despite this, its role remains controversial.
Materials and methods: This study was a single-center
RCT, patients with histologically proven resectable
pancreatic adenocarcinoma were randomized between
surgery alone (arm A) and neoadjuvant chemoradiation
followed by surgery (arm B). Accrual was completed
between May 2007 and July 2013 and results of our trial
were published in 2015. Five year after we would like to
assess the outcome in terms of overall survival (OS) and
disease-free survival (DFS). We used the intention-totreat approach and data were evaluated with KaplanMeyer method and compared using the log-rank test. In
the original study patients with no clear fat planes
around the celiac axis, hepatic artery, and superior mesenteric artery, as well as patients with more than 180°
maximal involvement of the superior mesenteric and
portal veins were excluded. The chemoradiation schedule consisted initially of chemotherapy with gemcitabine alone 1000 mg/m2 on days 1 and 8 every 21 days
for two cycles (total of 6 weeks) followed by combined
chemoradiotherapy for a total of 6 weeks (conventional
radiotherapy with 45 Gy and a boost of 9 Gy on the
pancreatic lesion; chemotherapy with gemcitabine 50
mg/m2 twice weekly).
Results: 38 patients were randomized: 20 in arm A and 18
in arm B. Median DFS was 8.53 months (95% CI, range
4.47-12.59) vs 18.03 months (95% CI, range 2.58-33.48)
for arm A and B respectively (p=0.242), while median OS
was 21.17 months (95% CI, range 8.37-33.96) for arm A
and 24.35 months (95% CI, range 8.04-40.66) for arm B
(p=0.174).
Conclusions: OS and DFS were not significantly different
between the two groups even if, especially DFS, they were
more favorable in the neoadjuvant group. The very low
power of this study suggests that this result could be due to
the underpowered data. Further multicenter RCTs with
more effective chemoradiotherapy regimens are needed in
order to better understand the real impact of chemoradiotherapy for resectable pancreatic cancer.



Tumori Journal Abstract Book - October 2020

Table of Contents for the Digital Edition of Tumori Journal Abstract Book - October 2020

Contents
Tumori Journal Abstract Book - October 2020 - Cover1
Tumori Journal Abstract Book - October 2020 - Cover2
Tumori Journal Abstract Book - October 2020 - I
Tumori Journal Abstract Book - October 2020 - II
Tumori Journal Abstract Book - October 2020 - Contents
Tumori Journal Abstract Book - October 2020 - IV
Tumori Journal Abstract Book - October 2020 - V
Tumori Journal Abstract Book - October 2020 - 1
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